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A Study Comparing MRG004A Plus Best Supportive Care Versus Placebo and Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Cancer

ConditionAdvanced Pancreatic Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLepu Biopharma Co., Ltd.

About this trial

This is a randomized, double-blind, multi-center, phase III study to evaluate the efficacy and safety, pharmacokinetic profile and immunogenicity of MRG004A in patients with advanced pancreatic cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing to sign the informed consent form and follow the requirements specified in the protocol.

Patients with histologically and cytologically confirmed locally advanced or metastatic pancreatic cancer, including adenocarcinoma, who have failed at least prior systemic therapies including gemcitabine and fluorouracil.

Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1).

The score of ECOG for performance status is 0 to 2.

Disqualifiers

History of other primary malignant tumors

Active metastasis to brain or meninges

Active acute or chronic inflammatory skin disease, history of Steven-Johnson syndromes

History of active or chronic corneal and conjunctival diseases, or other clinically significant ocular diseases that affect the ophthalmic monitoring of the investigational drug

Trial design

Design model

Parallel

Treatments tested in this trial

  • MRG004A plus best supportive care

    Drug

    MRG004A will be administrated as specified in the protocol.

  • Placebo plus best supportive care

    Drug

    Placebo will be administrated as specified in the protocol, following the same dose regimen as MRG004A.

Treatment groups

231 Participants
are divided into 2 treatment groups
Group A: Experimental ArmExperimental treatment 1 intervention
Group B: Control ArmPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

OS is defined as the duration from the start of treatment to death of any cause.

Time frame
Baseline to study completion (up to 24 months)

Secondary outcomes

1

Progression Free Survival (PFS)

PFS is defined as the duration from the start of treatment to the onset of tumor progression or death of any cause.

Time frame
Baseline to study completion (up to 24 months)
2

Objective Response Rate (ORR)

ORR is defined as the proportions of patients with a complete response (CR) and partial response (PR). ORR will be assessed according to RECIST v1.1.

Time frame
Baseline to study completion (up to 24 months)
3

Disease Control Rate (DCR)

DCR is defined as the proportion of subjects achieving CR, PR, and stable disease (SD) after treatment.

Time frame
Baseline to study completion (up to 24 months)
4

Duration of Response (DOR)

The time interval between the date of the earliest qualifying response and the date of disease progression or death for any cause, whichever occurs earlier.

Time frame
Baseline to study completion (up to 24 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lepu Biopharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: